PFS MARKET TRENDS - Partnerships With Pharma Packaging Specialists Will be Key to PFS Product Success in 2024

INTRODUCTION

The pre-filled syringe (PFS) market continues its steep growth trajectory. From a global market valuation of US $4.5 billion in 2022, it is anticipated to reach $5.53 billion by 2029, with a steady compound annual growth rate of 2.9%.¹ Looking ahead in 2024 and beyond, the secondary packaging chosen for PFS will play an increasingly pivotal role in steering the sector’s de­velopment.

Essential to ensuring this anticipated growth is the successful integration of innovations into mainstream PFS packaging. Strate­gic advancements in design and manufacturing will benefit vari­ous pharma sectors, with a focus on developing solutions for enhanced user-friendliness in self-administration.

Despite the promising landscape, adopting novel PFS pack­aging presents a formidable challenge for many pharmaceutical entities, especially small-size drug developers. The capital invest­ments necessary for upgrading manufacturing lines, coupled with the potential uncertainty surrounding the selection of optimal so­lutions tailored to the unique demands of treatments, can be a daunting hurdle in embracing new technologies.

To overcome these challenges in 2024, pharma companies need to establish close partnerships with specialists focusing on PFS packaging. This is critical for navigating obstacles and thriv­ing in the evolving sector landscape.

The following examines the innovations set to transform PFS packaging in 2024 and outlines the benefits of partnering with packaging experts to craft patient-centric PFS products, ensuring security and success in the coming year.

PATIENT-CENTRIC SOLUTIONS: THE PFS USER EXPERIENCE

The self-administration of injectable medications has histor­ically posed significant challenges for patients. The complexities involved in manually preparing syringes pose inherent risks of medication errors and contamination. These errors can arise from miscalculations in the preparation process that lead to compro­mised sterility or inaccuracies in dosage. Such issues present sub­stantial obstacles to patient well-being, potentially causing adverse reactions or undermining treatment efficacy, emphasising the need for precision and safety in syringe preparation.

In response to the need for patient-centric solutions to enable more seamless self-administration, the pharmaceutical sector has dedicated substantial research and development resources to en­hance the user experience. The development of the PFS has been a tangible outcome of these endeavours.

PFS presents pivotal advantages over the traditional vial and syringe approach. As PFS contain precisely measured single doses of medication, the risks associated with under- or over-dos­ing are effectively mitigated, ensuring a safer and more conven­ient user experience. This makes a PFS an optimal choice for patients who would otherwise need to visit a clinic to have med­ication administered. By using a PFS, patients can self-administer medication comfortably from home, eliminating the inconven­ience of frequent clinic visits associated with traditional syringe methods.

UNLOCKING THE POTENTIAL OF SECONDARY PACKAGING

To unleash the full potential of PFS, it’s crucial to have appropriate packaging. This ensures patients have what they need for accurate and safe treatment.

Beyond aesthetic appeal or providing a vessel for storing and transporting treat­ment doses, packaging plays a pivotal role in upholding the integrity of medicines, en­hancing user convenience and supporting adherence.

Preserving Medicine Integrity
Packaging amplifies the value of PFS self-administration by helping to ensure patient safety in different ways:

• Combatting Counterfeiting: Drug counterfeiting poses a substantial threat to patient safety and the overall integrity of the global supply chain. Some 13.6% of medicines in low- and middle-in­come countries are estimated to be sub­standard or falsified, with this percentage increasing to 19.1% for an­timalarials.^2,3 Those statistics, coupled with a 101% surge in counterfeit drug seizures during 2021 compared to the preceding year highlight the urgent challenge confronting pharmaceutical companies.⁴ To address this, govern­ments have implemented legal require­ments for “serialisation” — unique identifiers on drug packaging to prevent falsified medicines from infiltrating the supply chain. Legal frameworks, such as the EU Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA), Phase 2, establish the legal requirements for authenticity and traceability.
• Ensuring Stability & Shelf-Life: Second­ary packaging must shield the primary packaging and, consequently, the prod­uct, from breakage and environmental exposure to ensure optimum shelf life. New advancements in packaging de­sign are vital to maximise the stability and longevity of drug formulations. This is particularly the case now with drug products potentially having to travel long distances across international bor­ders, which increases the risk of break­age or temperature excursions.

Facilitating User Convenience
Secondary packaging also contributes to greater convenience and comfort for self-administration by:

• Streamlining Usability: The right sec­ondary packaging facilitates efficient kitting, allowing the incorporation of additional materials such as swabs, re­placement needles, usage instructions and informative content. This enhances PFS useability, extending the range of injectable treatments that patients can self-administer.
• Explaining to Patients How to Apply Their Treatments: Clear labelling and easily understandable instructions are paramount for patients to prepare, in­ject and safely dispose of PFS. Providing straightforward guidance in the patient’s language ensures a seamless self-administration process.
• Ensuring Safety for Vulnerable Demo­graphics: With the rise of self-adminis­tration, the risk of children encountering hazardous drugs increases. Child-proof secondary packaging is crucial, pre­venting unsupervised access and ensur­ing safety.

ADVANCEMENTS FOSTERING PATIENT CENTRICITY & SAFETY

The potential advantages of second­ary packaging for PFS extend beyond con­ventional benefits. The pharmaceutical industry increasingly acknowledges the un­tapped potential of packaging to elevate the patient centricity of PFS treatments.

Due to technological progress, sev­eral key innovations in secondary packag­ing are gaining prominence and are anticipated to be a central focus for new PFS products in the near future.

Smart Labels to Support Serialisation & Legal Compliance
In 2024, emerging solutions to sup­port compliance with serialisation legisla­tion may lie in smart labels featuring radio-frequency identification (RFID) or near-field communication (NFC) technol­ogy. These labels provide more robust in­formation than traditional counterparts, including unique identifiers and serialisa­tion data critical for compliance with the latest regulations while facilitating seam­less scanning during transport. Smart la­bels have the potential to harmonise data systems across the pharmaceutical supply chain, aligning serialisation compliance with operational efficiency.

Tamper-Evident Seals to Further Improve Patient Safety
Tampering, a concern linked to coun­terfeiting, poses a risk to patient safety. The alteration of packaging or labels can lead to substandard or falsified medications, jeopardising patient health. To address this, anti-tampering devices have been mandated in the EU for prescription med­icines since February 2019.⁵ Innovations over the next year aim to enhance these devices, ensuring any alterations are visi­ble to patients and streamlining installa­tion during filling and packaging.

Temperature-Sensitive Packaging to Sup­port Cold Chains
Given the heightened sensitivity of bi­ologics to environmental factors, there is a growing demand for temperature-con­trolled transit. The pharmaceutical cold-chain logistics market is anticipated to witness substantial growth, by $11.6 bil­lion from 2022 to 2027, emphasising the importance of minimising temperature ex­cursions.⁶ Smart labels can potentially aid pharmaceutical companies by allowing real-time monitoring of temperature con­ditions during product transport. Processor cores within these labels can enable data transmission to a central database, allow­ing the identification and disposal of units with temperature excursions. This system aids in understanding the root cause of ex­cursions, preventing future occurrences.

Kit Innovations Enhance Useability for Vulnerable Patients
Ongoing developments in kit packag­ing and associated manufacturing equip­ment aim to make PFS more user-friendly, especially for vulnerable patients. Alterna­tive ergonomic grips can be packaged within kits, offering diverse options for pa­tients, particularly older individuals with manual dexterity issues. These innovations empower patients with greater confidence in self-administering treatments, promot­ing independence and autonomy.

EMPOWERING PACKAGING THROUGH STRATEGIC COLLABORATION

Navigating the adoption of these in­novations for the first time can be a daunt­ing prospect, particularly considering the substantial capital expenditure required for equipment acquisition and installation.

To overcome these hurdles, an in­creasing number of pharmaceutical com­panies are forging strategic partnerships with expert contract packaging organisa­tions (CPOs). In doing so, these compa­nies can leverage the latest packaging innovations without the need for substan­tial individual investments. These strategic alliances are poised to alter the industry’s trajectory, fostering efficiency and deliver­ing enhanced patient experiences.

Equipped with the necessary infra­structure and capacity, CPOs play a pivotal role in supporting the industry in gaining early, efficient and effective access to inno­vations that support the launch of progres­sively patient-centric and complex dosage forms. Their ability to meticulously fill and seal high volumes of PFS in a sterile envi­ronment eliminates the need for pharma­ceutical companies to invest in dedicated equipment themselves. This ensures com­pliance with rigorous regulatory standards, such as Annex 1 of the EU Guidelines for Good Manufacturing Practice, and guar­antees the delivery of safe, high-quality and convenient products to patients.⁷

Beyond infrastructure, CPOs can pro­vide pharmaceutical manufacturers with invaluable insights into the distinctive packaging requirements of their products. They offer flexibility and capacity to de­velop customised packaging services, adding tangible value for customers and establishing enduring partnerships.

Moreover, the collaboration between pharmaceutical companies and packaging providers extends be­yond operational efficiencies. CPOs contribute to improved branding and product promotion by aiding in the creation of packaging designs that resonate with target audiences. This col­laborative approach effectively communicates product benefits, ensuring that these pharmaceutical innovations stand out in the competitive marketplace.

FINDING SUCCESS WITH THE RIGHT PARTNER

Seamless coordination between the sponsor pharmaceutical company and packaging providers right from the initial stages of product development is key to the success of any pharmaceutical product. This alignment is imperative for a complex dosage form like a PFS, given its intricate secondary packaging requirements. Early partnership is vital, especially for companies aspiring to leverage the advancements in patient convenience and supply chain security anticipated in 2024.

Starting collaboration from the project’s inception allows manufacturers and CPOs to synergise their expertise. The fusion of expertise and capabilities optimises the cost-effectiveness, time efficiency, and sustainability of packaging designs, culminating in a process that streamlines time-to-market. Due to companies embracing this collaborative approach in 2024, a growing num­ber of patients can benefit from novel treatments, enhanced by more efficient packaging solutions and delivered to market faster than ever before.

REFERENCES

1. https://www.marketreportsworld.com/TOC/23793024.
2. https://jamanetwork.com/journals/jamanetworkopen/ fullarticle/2696509.
3. https://www.who.int/features/factfiles/malaria/en/.
4. https://www.psi-inc.org/incident-trends.
5. https://finance.yahoo.com/news/cold-chain-logistics-market-pharmaceuticals-000000427.html.
6. https://www.ema.europa.eu/en/news/new-safety-features-medicines-sold-eu.
7. https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf.

Pieter Vercruysse is VP of Customer Success and Supply Chain at Tjoapack. He joined Tjoapack in 2009 and has had several roles within the company, including QA/QP, Innovation Manager and Director of Operations. He is responsible for key account management, implementation of new products and processes, artwork, data management, and customer services. He earned a Master’s degree in Pharmaceutical Sciences.